Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression
Completed · Not applicable
Conditions studied: Depression
In brief
Depression is a common psychological disorder seen in 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF/OND Veteran's ability to improve work and home adjustment and overall quality of life. OEF/OIF/OND Veterans have reported many barriers to following through with Cognitive therapy skills practice assignments, a key component of CBT therapy, the leading therapy for depression in the VA. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. The investigators propose a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
Key facts
- Study ID
- NCT04002063
- Run by
- VA Office of Research and Development
- People needed
- 15
- Starts
- 2022-10-10
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2025-10-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veteran of OEF/OIF/OND deployments
- Depressive severity of at least 10 on the PHQ-9 at screening (Patient may also have a DSM-5 56 diagnosis of unipolar Major Depression; PTSD; any anxiety disorder; substance/alcohol abuse; or adjustment disorder)
- Ability to read at the eighth grade level and to provide informed consent
- Patients may be taking antidepressants or antianxiety medications where dose has been stable for at least 4 weeks prior to screening evaluation
- Must have an Android smartphone
- Must be willing to be audio-taped for fidelity ratings
You may not qualify if…
- Diagnoses of schizophrenia, schizo-affective, bipolar, or other psychotic disorder
- Serious suicidal risk (Patient responds positively to PHQ-9 question #9) See B.3.4.1.
- Severe PTSD (Score greater than 51 on PTSD Checklist for DSM-5)
- Severe substance or alcohol dependence (meets DSM-5 criteria of severe)
Where it is running
- Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
- Rehabilitation R&D Service, Baltimore, MD — Baltimore, Maryland, United States
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
- Coatesville VA Medical Center, Coatesville, PA — Coatesville, Pennsylvania, United States
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
- Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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